CN106265758A

CN106265758A - One treats vasculitic Chinese patent medicine

Info

Publication number: CN106265758A
Application number: CN201510241499.XA
Authority: CN
Inventors: 蒋蓉
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-05-13
Filing date: 2015-05-13
Publication date: 2017-01-04

Abstract

The invention discloses one and treat vasculitic pharmaceutical composition, belong to pharmaceutical technology field.The composition of the present invention is: Venenum Bufonis 0.5-2.5 part, Squama Manis 50-170 part, Hirudo 30-120 part, Plumbum preparatium 10-50 part, makes various different oral medicine dosage form with conventional pharmaceutical excipients and conventional pharmaceutical technology.The medicine of the present invention has carried out acute toxicity test, accumulation toxicity test to animal, it was demonstrated that safety, and clinical observation cure rate is effective, has preferable promotional value.

Description

One treats vasculitic Chinese patent medicine

Technical field

The present invention relates to pharmaceutical technology field, particularly relate to one and treat vasculitic Chinese patent medicine.

Background technology

One of vasculitis difficult disease being referred to as Medical circle, though this disease is difficult to jeopardize human life, but easily cause animally and the most immeasurable misery to patient, because of currently without real clinical medicine, cure rate is extremely low, great majority finally torment taking the medical procedure of amputation to save bigger disease from damage, thus bring to patient is lifelong misery.In terms of the most clinical medicine, mainly use the medicines such as FUFANG DANSHEN PIAN (capsule), Radix Salviae Miltiorrhizae Injection, snake venom antithrombotic enzyme, by expansion, the Therapeutic Principle such as blood vessel, antiplatelet cohesion delays the amputation time, thus performance over the course for the treatment of be time length, curative effect slowly, costly, relapse rate is high, side effect is big, therefore seek one and treat vasculitic medicine, particularly Chinese patent medicine, be to treatment this disease of vasculitis in the urgent need to.

Summary of the invention

The invention aims to improve the deficiency of prior art, and it is fast to provide one to have curative effect, treatment time is short, and expense is low, without the Chinese patent medicine being exclusively used in treatment vasculitis diseases of recurrence after controlling.

It is an object of the invention to be achieved by the following technical programs, one treats vasculitic pharmaceutical composition, and its composition is:

Venenum Bufonis 0.5-2.5 part, Squama Manis 50-170 part, Hirudo 30-120 part, Plumbum preparatium 10-50 part

The preferable amount proportioning of said components is:

Venenum Bufonis 1-2 part, Squama Manis 80-120 part, Hirudo 50-100 part, Plumbum preparatium 20-35 part

The optimum weight proportioning of pharmaceutical composition of the present invention is:

Venenum Bufonis 1.5 parts, Squama Manis 100 parts, Hirudo 80 parts, 30 parts, Plumbum preparatium

Above-mentioned pharmaceutical composition can be equipped with conventional pharmaceutical excipients according to conventional Chinese medicine preparation technology and be prepared as any conventional pharmaceutical dosage form such as common formulations clinically, such as pill, powder, tablet, sugar coated tablet, sublimed preparation, capsule etc..

Thromboangiitis obliterans is a kind of pernicious thrombus disease, it is tremulous pulse and systemic disease that vein is got involved simultaneously, and may result in the generation of Other diseases, theory of Chinese medical science is thought: direct stimulation, impairment caused by overstrain are excessive, heart kidney two can be made to lose, deficiency of heart-blood, blood vessels run the most smooth, kidney water loses, and fire is the most high mutually, and occurs heart kidney to lack of proper care, insufficiency of primordial QI, so that the imbalance of the four stages in the course of an epidemic febrile disease transporting, it is impossible to dissipate and be skillful in blood vessels, and gradually form deficiency of both QI and blood, add cold again to endure cold, cold-evil is dissolved in meridians, and makes coagulation of QI-blood, and yang-energy can not be assigned and fall ill.

The diseases such as effect of medicine of the present invention is: Venenum Bufonis is warm in nature, and sweet in the mouth is pungent, poisonous, has removing toxic substances and promoting subsidence of swelling, and pain relieving is had one's ideas straightened out, the effect of topical anesthesia, cures mainly carbuncle poison furuncle, laryngopharynx swelling and pain, external application or take medicine orally；Squama Manis cold nature, salty in the mouth, there is eliminating stasis and resolving masses, eliminating carbuncle evacuation of pus, be to draw prescribe medicine simply, penetrate meridians, through sick institute；Hirudo property is put down, and salty in the mouth is bitter, slightly poisonous, has removing blood stasis power strong, and removing blood stasis with potent drugs stimulates the menstrual flow, and cures mainly the diseases such as blood stasis amenorrhea, lump in the abdomen, blood-retention, and because Hirudo eating human blood and property are slow, slow, hemopoietic is not hindered, and is apt to into then hard long-pending fragile, by means of its power, to attack its stasis of accumulating in the course of time；Plumbum preparatium is cold in nature, poisonous, has removing toxic substances, blood stasis dispelling, effect of granulation promoting.The overall efficacy of pharmaceutical composition of the present invention is: strengthening heart and boosting pressure, vigorous blood circulation, anticoagulation, the formation of thrombosis, it is possible to expansion blood vessel, blood fat reducing, reduce blood viscosity, have convergence, sterilize, subside a swelling, the effect of granulation promoting, α-hemolytic streptococcus, staphylococcus aureus are had inhibitory action, inhibited to platelet aggregation, minimizing to leukocyte can be allowed to, and can improve cellular immunization and humoral immune function.Show according in vitro tests: this medicine can make the setting time of fibrin stock solution extend, and has antithrombase sample effect and urokinase sample effect, makes fibrin solution activation.

Test example

(1) animal toxicity test

In inventive formulation, Venenum Bufonis, Hirudo, Plumbum preparatium are all toxic pharmaceuticals, and single uses and people all can be made to be poisoned to death, but in this programme, the synthesis of four Chinese medicine active ingredient can make toxicity reduce, and the cumulative action of lead ion reduces.Publish according to learning centre described in " the practical toxic herb clinic handbook " of the high clear stricture of vagina comrade chief editor that Du publishes: the LD50 (mg/kg) of white mice is by Venenum Bufonis: intravenous injection 41.0, subcutaneous injection 96.60, lumbar injection 36.24, Hirudo is to female white mice subcutaneous injection Hirude decoction, LD50 is 15.24g/kg, toxic dose 15-30g for oral administration, and Plumbum preparatium crisp injection LD50 quiet to mice is 16.70g/kg, the LD50 that rat abdominal cavity is administered is 220mg/kg, and animal toxicity test is:

1, acute toxicity test

(1) oral medication:

1. take medicine 2g of the present invention to add water to grind and make full dose become the homogenate (concentration is 50mg/ml) of 40ml standby.

2. white mice 20 (each 10 of male and female) is taken, every white mice gives sample equal serosity 0.02ml/g gavage (being equivalent to 1000mg/kg) according to the weight, observe 10 days, the all healthy existence of white mice, without any toxicity, through anatomic observation hemogram, liver function, each organs and tissues morphology finding compares zero difference with matched group.The dosis tolerata that white mice is administered orally by this product is at more than 1000mg/kg.

null3. white mice 20 (each 10 of male and female) is taken，Every white mice is grouped (often group 10) the most respectively and gives sample equal serosity 0.03ml/g and 0.04ml/g gavage (is respectively equivalent to 1500mg/kg、 2000mg/kg)，Observe 10 days，The all healthy existence of the white mice of gavage 0.03ml/g group，Without toxicity，Through anatomic observation hemogram、Liver function，Each organs and tissues morphology finding compares zero difference with matched group，The white mice of gavage 0.04ml/g group showed the dysphoria of degree of having nothing in common with each other in 10 days，Stupor，The most dead 2，Account for 20%，Abnormal through anatomic observation routine blood test，Lead content in urine is slightly higher，Liver function is normal，Other each organs and tissues no abnormality seen，Another pneumorrhagia is found during 2 dead white mice are dissected，The maximum tolerated dose that white mice is administered orally by medicine the most of the present invention is at 1500mg/kg，LD to mice) 50 (mg/kg) are 2000.

2 accumulation toxicity tests

(1) mouth medication:

1. take medicine 1g of the present invention to add water to grind and make full dose become the homogenate (concentration is 25mg/ml) of 40ml standby.

2. white mice 40 (each 20 of male and female) is taken, every white mice gives sample equal serosity 0.02ml/g gavage (being equivalent to 500mg/kg) once a day according to the weight, observe three months, the all healthy existence of white mice, without any toxicity, through anatomic observation hemogram, liver function, each organs and tissues morphology finding compares zero difference with matched group, internal substantially without accumulation.

Show through toxicity test, this medicine is at 1500mg/kg to the maximum tolerated dose of mice, to the LD50 of mice at more than 2000mg/kg, the accumulation toxicity test of mice is shown that the oral dose of 500mg/kg is without accumulation, it is 400mg higher than clinical program adult's consumption, child's consumption is 150mg, and children under three years of age should not take, and this medicine is safe to patient.

The clinical practice of medicine of the present invention:

Medicine of the present invention carries out clinical practice in 8 hospitals to vasculitis diseases patient, receives altogether treatment patient 356 people, sick time elder 42 years, the shortest has 6 months, treatment time the longest for 60 days, the shortest for 20 days, 326 people wherein fully recovered, account for 91.6%, 25 effective people, account for 7%, 5 invalid people, accounting for 1.4%, total effective rate reaches 98.6%.Through patient after curing is followed up a case by regular visits to, patient's complete recovery of health, identical with normal person work, do not find any untoward reaction produced because taking this medicine during treatment.Now typical case's case history is taken passages as follows:

1, ×× is opened, man, 76 years old, retirement, first visit on May 28 in 1993, existing 8 years as long as of patient's self-induction paroxysmal pain, ant sense is obvious, ulcus cruris, night severe pain unbearably, life is rough with take care of oneself, repeatedly arrive hospital therapy, effect is the most inconspicuous, is biped vasculitis after diagnosing, through taking medicine of the present invention (each 400mg, three times a day), after 5 days, pain disappears, recovery from illness in 20 days, so far follow up a case by regular visits to, without any recurrence and untoward reaction, remain to engage in physical work.

2, grandson's ×× man, 36 years old, worker, patient's JIUYUE 16 mesh first visit in 2010, 3 years front left medial legs of readme have two red lines, swelling pain, disappear through hospital treatment red line, hereafter left foot thumb starts pain, the most uninterruptedly take relevant medicine 3 years, symptom fails to alleviate all the time, the pain increased, left foot big toe is downright bad, toenail comes off, other toenail yellowing, thickening, do not grow, left leg atrophy, depending on YANG pulse, Taixi arteries and veins disappears, yellowish fur, complexion is sallow, lackluster, it is diagnosed as three stage angiitis, through taking medicine of the present invention (each 400mg, 3rd day pain relief three times a day), after 10 days, pain almost disappears, pulse gradually recovers, sequestrum Automatic-falling after treating 20 days, recovery from illness in 55 days. follow up a case by regular visits to So far patient body is in order, has no any untoward reaction, makes us equally engaging in physical work with same.

3, woods ××, man, 66 years old, peasant, first visit on June 12 in 2011, patient's readme, when farming operation in 2005, was cut heel, secondary infection by colter, is fully recovered by hospitalize；Next year recurs, the state of an illness is aggravated, left leg by amputation to knee joint. modern aggravation, lower limb pain is unbearably, the thickening blackening of amputation site Huang scab and harden, right lower limb severe atrophy, skin is dim, turn black and nonelastic, depending on a cun GUAN-pulse weak pulse stringy and thready pulse, this patient mental is dispirited, One's face was like wax, deep red tongue, through taking medicine of the present invention (each 400mg, three times a day) after 10 days, pain disappears, within 30 days, double limb colors are gradually recovered, muscle begins with elasticity, fully recover after taking medicine 60 days, life can take care of oneself, follow up a case by regular visits to so far, patient body is normal, there are not untoward reaction and the sense do not relaxed.

The following detailed description of a kind of specific embodiments treating vasculitic Chinese patent medicine of the present invention.

Embodiment 1

Weigh Venenum Bufonis 0.5kg, Squama Manis 50kg, Hirudo 30kg, Plumbum preparatium 10kg, size-reduced, sieve after make sugar coated tablet 90.5 × 10 by conventional manner technique⁴Sheet (every 0.1g), i.e. obtains the sugar coated tablet of medicine of the present invention, and packs with little glass medicine bottle, the most bottled 100.

Embodiment 2

Weigh Venenum Bufonis 2.5kg, Squama Manis 170kg, Hirudo 120kg, Plumbum preparatium 50kg, size-reduced, sieve after add Mel 3 kilograms as pharmaceutical excipients, and by produce pill or sublimed preparation conventional manner technique to make quantity be 172.75 × 10⁴Individual pill (every ball 0.2g) or to make quantity be 345.5 × 10⁴Individual medicine red (every red 0.1g), i.e. obtains the pill of medicine of the present invention, sublimed preparation, and packs with vial.

Embodiment 3

Weighing Venenum Bufonis 1kg, Squama Manis 80kg, Hirudo 50kg, Plumbum preparatium 20kg, size-reduced sieve, making quantity after adding necessary pharmaceutical excipients (such as magnesium stearate) by conventional manner technique is 151 × 10⁴Individual tablet (every 0.1g), i.e. obtains the tablet of medicine of the present invention, and packs with bottle, 100 every bottle.

Embodiment 4

Weigh Venenum Bufonis 2kg, Squama Manis 120kg, Hirudo 100kg, Plumbum preparatium 35kg, size-reduced sieve after, pharmaceutical technology makes powder routinely, and blend compounds capsule carries out fractional pack, dresses up Caplet 257 × 10 altogether⁴Grain (each dress 0.1g powder), and pack with bottle, 100 every bottle, i.e. obtain the capsulation dosage form of medicine of the present invention.

Embodiment 5

Weigh Venenum Bufonis 1.5kg, Squama Manis 100kg, Hirudo 80kg, Plumbum preparatium 30kg, pulverize, sieve, mix, and make powder by conventional manner technique and be loaded on vial, and in Packaging Bottle, be furnished with the little spoon of metering 0.1g, every bottled 10g, fill 211.5 × 10³Bottle, i.e. obtains the powder of medicine of the present invention.

Claims

1. treat a vasculitic pharmaceutical composition, it is characterized in that its composition is: Venenum Bufonis 0.5-2.5 part, Squama Manis 50-170 part, Hirudo 30-120 part, Plumbum preparatium 10-50 part.

Pharmaceutical composition the most according to claim 1, is characterized in that its composition is: Venenum Bufonis 1-2 part, Squama Manis 80-120 part, Hirudo 50-100 part, Plumbum preparatium 20-35 part.

Pharmaceutical composition the most according to claim 1, is characterized in that its composition is: Venenum Bufonis 1.5 parts, Squama Manis 100 parts, Hirudo 80 parts, 30 parts, Plumbum preparatium.

4., according to the pharmaceutical composition described in claim 1 or 2 or 3, it is characterized in that the dosage form of this medicine is any conventional pharmaceutical dosage form such as pill, powder, tablet, sugar coated tablet, sublimed preparation, capsule.

Pharmaceutical composition the most according to claim 4, is characterized in that this medicine is possibly together with conventional pharmaceutical excipients.